Ignite Creation Date:
2024-05-06 @ 1:12 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03951545
Status:
UNKNOWN
Last Update Posted:
2019-05-15
First Post:
2018-11-07
Brief Title:
Clinical and Radiological Impact of Tibial Cutting Int Total Knee Arthroplasty Accelerated Navigation Versus Extramedullary Targeting
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Clinical and Radiological Impact of Tibial Cutting Int Total Knee Arthroplasty Accelerated Navigation Versus Extramedullary Targeting a Randomized Prospective Study
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Type of study
Superiority study comparative randomized double-blind patient and evaluator will be blind from the randomization group multicenter prospective inclusion Two groups of patients will be compared a group of patients whose tibial sections will be performed using extramedullary mechanical sighting and a group whose tibial sections will be performed using gyroscopic and accelerometric navigation I-Assist will be randomized Randomization will be performed with a 11 ratio per block
Population
Patients requiring 1st line total knee replacement for gonarthrosis with a Hip knee angle HKA between 170 and 183 who have agreed to participate in the study Patients who have already undergone surgery on the same knee uni-compartmental prosthesis total knee replacement tibial or femoral osteotomy for re-alignment with the exception of arthroscopy or who have vicious calls will not be included in the study
The number of subjects required was calculated using NQUERY 40 software for the main endpoint data with the following assumptions 51 of patients reaching the tibial cut target angles for the extramedullary mechanical aiming technique and 68 of patients reaching the tibial cut target angles for the I-Assist gyroscopic and accelerometric navigation technique With an alpha risk of 5 a power of 90 and bilateral test the number was estimated at 174 per group Taking into account a percentage of included patients for whom total knee arthroplasty will not be performed of 10 it is planned to include a total of 382 patients
Main judgment criteria
Achievement of the target tibial slope of 3-2 and the target tibial varusvalgus at -2 The tibial slope is defined by the angle in degrees between the mechanical axis of the tibia in profile and the tangent to the tibial cut The varusvalgus tibial is the angle formed between the mechanical axis of the front tibia and the tangent to the tibial cut
Investigation plan
Proposal to participate in the research to any eligible patient at the time of a preoperative consultation with the orthopaedic surgeon If the patient agrees to participate in the research signature of the informed consent form a randomization will be performed to determine the group of bone cutting technique The patient will be blind to the result of randomization
The clinical follow-up of the patient will not be modified by the study with as usual
A 6-week consultation with interrogation clinical and radiographic examination Face and profil x-rays axial patella views
A 3-month consultation with interrogation clinical and radiographic examination Face and profil x-rays axial patella views telemetry of the lower limbs in charge and full profile leg x-rays
Measurements of the radiographic judgement criteria will be performed by two orthopaedic surgeons and a blind radiologist of the cutting technique used The tibial slope will be analyzed on the entire leg radiograph in profile at 3 months Coronal alignment will be studied on telemetry of the front lower limbs loaded at 3 months
Joint amplitudes and patient satisfaction will be assessed at 3 months postoperatively with the New IKS score by a blind surgeon of the surgical technique used
Statistical analysis plan
Comparison of the characteristics of the 2 groups
Analysis of the main endpoint comparison of the percentage of patients with the target tibial slope achieved in both groups by Chi2 test or an accurate Fisher test depending on the application conditions
Analysis of secondary judgment criteria by Student Wilconxon Chi2 or exact Fisher tests depending on the application conditions
Superiority study comparative randomized double-blind patient and evaluator will be blind from the randomization group multicenter prospective inclusion Two groups of patients will be compared a group of patients whose tibial sections will be performed using extramedullary mechanical sighting and a group whose tibial sections will be performed using gyroscopic and accelerometric navigation I-Assist will be randomized Randomization will be performed with a 11 ratio per block
Population
Patients requiring 1st line total knee replacement for gonarthrosis with a Hip knee angle HKA between 170 and 183 who have agreed to participate in the study Patients who have already undergone surgery on the same knee uni-compartmental prosthesis total knee replacement tibial or femoral osteotomy for re-alignment with the exception of arthroscopy or who have vicious calls will not be included in the study
The number of subjects required was calculated using NQUERY 40 software for the main endpoint data with the following assumptions 51 of patients reaching the tibial cut target angles for the extramedullary mechanical aiming technique and 68 of patients reaching the tibial cut target angles for the I-Assist gyroscopic and accelerometric navigation technique With an alpha risk of 5 a power of 90 and bilateral test the number was estimated at 174 per group Taking into account a percentage of included patients for whom total knee arthroplasty will not be performed of 10 it is planned to include a total of 382 patients
Main judgment criteria
Achievement of the target tibial slope of 3-2 and the target tibial varusvalgus at -2 The tibial slope is defined by the angle in degrees between the mechanical axis of the tibia in profile and the tangent to the tibial cut The varusvalgus tibial is the angle formed between the mechanical axis of the front tibia and the tangent to the tibial cut
Investigation plan
Proposal to participate in the research to any eligible patient at the time of a preoperative consultation with the orthopaedic surgeon If the patient agrees to participate in the research signature of the informed consent form a randomization will be performed to determine the group of bone cutting technique The patient will be blind to the result of randomization
The clinical follow-up of the patient will not be modified by the study with as usual
A 6-week consultation with interrogation clinical and radiographic examination Face and profil x-rays axial patella views
A 3-month consultation with interrogation clinical and radiographic examination Face and profil x-rays axial patella views telemetry of the lower limbs in charge and full profile leg x-rays
Measurements of the radiographic judgement criteria will be performed by two orthopaedic surgeons and a blind radiologist of the cutting technique used The tibial slope will be analyzed on the entire leg radiograph in profile at 3 months Coronal alignment will be studied on telemetry of the front lower limbs loaded at 3 months
Joint amplitudes and patient satisfaction will be assessed at 3 months postoperatively with the New IKS score by a blind surgeon of the surgical technique used
Statistical analysis plan
Comparison of the characteristics of the 2 groups
Analysis of the main endpoint comparison of the percentage of patients with the target tibial slope achieved in both groups by Chi2 test or an accurate Fisher test depending on the application conditions
Analysis of secondary judgment criteria by Student Wilconxon Chi2 or exact Fisher tests depending on the application conditions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None